Description

Intended use: CTS™ Immune Cell SR is intended to be used as a serum replacement in cell and tissue culture of clinical samples. The product is for in vitro diagnostic use.CTS™ Immune Cell Serum Replacement (SR) is designed to support expansion of in vitro cultured human immune cells such as T cells when added to a basal cell culture media such as CTS™ OpTmizer™ T cell Expansion SFM or CTS™ AIM-V® SFM. CTS™ Immune Cell SR is a defined xeno-free formulation and does not contain bovine or other non-human, animal-derived components.• Minimizes the supply and safety risks associated with human serum• Supports expansion of polyclonal T cells (CD3/CD28 bead-activated, OKT3 mAb-activated, virus-specific and tumor-specific T cells)• Supports T cell phenotype (CD4, CD8, and CD62L) similar to human serum• Supports expansion of gene-modified CAR T cells (lentiviral transduction)• Reduces the cost and time associated with qualifying human serum• Generic enough to use with the base media of your choiceSecurity of supply and safetyCTS™ Immune Cell SR is a defined xeno-free formulation that contains no bovine or other non-human, animal-derived components at the primary component level. The site is FDA registered and has an ISO13485-certified quality management system. The methods and controls used for the manufacturing are in conformity with current Good Manufacturing Practices for medical devices, 21 CFR Part 820, of the regulation. Full traceability documentation such as Certificate of Origin, Certificate of Analysis, and Drug Master File are available. The product can be scaled to meet future clinical and commercial demand. Alternate manufacturing sites are available as further risk mitigation.T cell qualifiedCTS™ Immune Cell SR can replace human serum at similar concentrations and achieve similar performance. CTS™ Immune Cell SR supports expansion of polyclonal T cells (CD3/CD28 bead-activated and TILs), T Cell phenotypes (CD4, CD8 and CD62L), and expansion of gene-modified CAR T cells (lentiviral transduction). Every lot is pre-qualified in a functional T cell assay using CTS™ Dynabeads® CD3/CD28-activated primary T cells to ensure consistent performance. This reduces the cost and time associated with human serum lot testing.VersatilityCTS™ Immune Cell SR can replace human serum at similar concentrations without sacrificing performance in several different base media such as CTS™ OpTmizer™ T Cell Expansion SFM and CTS™ AIM-V® SFM or other commercial media designed for immune cells. Varying dilutions of CTS™ Immune Cell SR should be tested to determine the optimal concentration needed for your cell type and basal media.What you getCTS™ Immune Cell SR is available in a 50 mL bottle for small volume users as well as a 500 mL bottle for larger volume users. For added convenience, the product can be freeze-thawed once if smaller aliquots are needed. CTS™ Immune Cell SR can be added to your standard base media at similar concentrations as human serum.For In Vitro Diagnostic Use.

Figures

\"CAR

CAR transduction efficiency of expanded T cells

\"ICSR

ICSR supplementation is equivalent to human serum for CAR engineered T cell expansion

\"Efficacy

Efficacy of CAR-modified T cells grown with ICSR

Specifications

Classification:Product Line:Product Size:Green Features:Shipping Condition:
Xeno-Free
CTS™
500 mL
Sustainable packaging
Dry Ice

Contents & storage

Store in freezer (-5 to -30°C).